SOURCE: Onset Dermatologics

Onset Dermatologics

February 28, 2012 08:30 ET

Onset Dermatologics Launches Aurstat® Kit

New Data Confirm Clinical Efficacy of Aurstat® Hydrogel in Reducing Itch Related to Atopic Dermatitis

CUMBERLAND, RI--(Marketwire - Feb 28, 2012) - Onset Dermatologics, a PreCision Dermatology company and a leader in developing and commercializing novel, prescription products for improving skin health, today announced the availability of Aurstat® Kit. Aurstat® Kit contains Aurstat® Skin & Wound Hydrogel and HylatopicPlus® Cream. Aurstat® Hydrogel is a treatment for itch, including itch related to atopic dermatitis and eczema. Aurstat® contains the key components of a bleach bath in an easy to use topical formulation. Bleach baths have been proven to improve the symptoms of atopic dermatitis1. HylatopicPlus® is a ceramide-rich, non-steroidal prescription therapy which incorporates hyaluronic acid to deliver a blend of physiologic lipids to restore healthy skin barrier function in patients with atopic dermatitis. The two products are packaged together for patient convenience.

"Itching is one of the most troublesome symptoms of atopic dermatitis, not only because of the patient discomfort it causes but also because it leads to scratching, which can worsen disease severity," noted Zoe Draelos, MD, FAAD, Consulting Professor in the Department of Dermatology, Duke University School of Medicine, Durham, NC.

Dr. Draelos recently presented the results of a study of Aurstat Hydrogel at the Winter Clinical Dermatology Conference, January, 2012 in Maui, Hawaii in a poster entitled, "Evaluation of a Gel Formulation of Hypochlorous Acid and Sodium Hypochlorite to Reduce Pruritus in Mild to Moderate Atopic Dermatitis". In this open-label, monadic study evaluating the effects of Aurstat® Hydrogel in 20 subjects with mild to moderate atopic dermatitis, Aurstat® reduced itch as early as Day 1. By Day 3, Aurstat® demonstrated a 44% reduction in itch, according to the subjects' assessment (P < 0.001). Subjects were provided with HylatopicPlus® on Day 3 with the option to use it up to 3 times per day. At the end of the study (Day 7), patients reported a 71% reduction in itching (P < 0.001). Nineteen of the twenty patients applied both therapies.

"Aurstat® Kit is an important addition to the Onset Dermatologics product line," said Jeff Wayne, General Manager, Onset Dermatologics. "Aurstat® Hydrogel quickly addresses itch, which is the key complaint of atopic dermatitis patients. HylatopicPlus® helps restore a healthy skin barrier function and has been clinically proven to improve the symptoms of atopic dermatitis. Aurstat® Kit offers a convenient approach for dermatology practitioners who wish to employ the two different non-steroidal therapies to address the symptoms of atopic dermatitis."

Aurstat® Kit is now available in the U.S. by prescription only.

About Atopic Dermatitis (Eczema)

Atopic dermatitis (eczema) is a common skin disorder characterized by red, inflamed, dry, cracked, itching skin. Atopic dermatitis is often called the "itch that rashes." Itching, which is sometimes intense, may start even before the rash appears. Scratching often contributes to worsening of the rash. Other symptoms may include blisters with oozing or crusting, changes in the skin tone and thickening of the skin called lichenification which can occur after long term irritation and scratching2. Eczema frequently affects children, with approximately 10.7 percent of all children experiencing a diagnosis within the past 12 months, according to a recent study3. Patients with eczema have a dysfunctional skin barrier, allowing excessive water loss increased allergen penetration through the epidermal layer of skin.

Important Safety Information for Aurstat® Hydrogel

Aurstat® Hydrogel is intended for use to relieve itch and pain from minor skin irritations, lacerations, abrasions and minor burns. Do not use in the eyes. The gel contains sodium hypochlorite and hypochlorous acid as preservatives to reduce/ prevent growth of microorganisms within the gel. The effect of this product in the wound bed has not been tested clinically. The safety and efficacy of combination use of Aurstat® and HylatopicPlus® have not been established. Each product can be used separately.

Important Safety Information for HylatopicPlus®

HylatopicPlus® Cream is indicated to manage and relieve, burning, itching and pain that can accompany skin dermatoses such as atopic dermatitis (eczema).

HylatopicPlus® is contraindicated in persons with a known hypersensitivity to any of the components of the formulation. If clinical signs of infection are present, appropriate treatment should be initiated; use of HylatopicPlus® Cream may be continued during the anti-infective therapy.

About Onset Dermatologics

Onset Dermatologics (www.onsetdermatologics.com) is dedicated to providing new, optimized, innovative, practical and cost-effective pharmaceutical products to the healthcare market in an effort to improve the quality of life for patients.

About PreCision Dermatology, Inc.

PreCision Dermatology (www.precisionderm.com) is a fully-integrated dermatology company with a mission to deliver innovative therapies to doctors and patients that demonstrably improve the care of skin. PreCision Dermatology is expanding quickly through acquisitions, in-licensing, co-marketing opportunities and internally generated therapies.

1 Huang JT, Abrams M, Tlougan B, Rademaker A, Paller AS. Treatment of staphylococcus aureus colonization in atopic dermatitis decreases disease severity. Pediatrics. 009;123:e808-e815.

2 PubMed Health. http://www.ncbi.nlm.nih.gov/pubmedhealth/PMH0001856/. Accessed February 17, 2012.

3 Shaw TE, Currie GP, Koudelka CW, Simpson EL. Eczema Prevalence in the United States: Data from the 2003 National Survey of Children's Health. J Invest Dermatol. 2011;131(1):67-73.

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